97-28017. Animal Drugs, Feeds, and Related Products; Selegiline Hydrochloride Tablets; Correction  

  • [Federal Register Volume 62, Number 205 (Thursday, October 23, 1997)]
    [Rules and Regulations]
    [Pages 55158-55159]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-28017]
    
    
    =======================================================================
    -----------------------------------------------------------------------
    
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Parts 510 and 520
    
    
    Animal Drugs, Feeds, and Related Products; Selegiline 
    Hydrochloride Tablets; Correction
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Final rule; correction.
    
    -----------------------------------------------------------------------
    
    SUMMARY: The Food and Drug Administration (FDA) is correcting a
    
    [[Page 55159]]
    
    final rule that appeared in the Federal Register of June 27, 1997 (62 
    FR 34631). The document amended the animal drug regulations to reflect 
    approval of a new animal drug application (NADA) filed by Deprenyl 
    Animal Health, Inc. The NADA provides for oral use of selegiline 
    hydrochloride tables for dogs for the control of clinical signs 
    associated with uncomplicated pituitary-dependent hyperadrenocorticism. 
    The approved use in dogs was inadvertently omitted from the document. 
    This document corrects that error.
    
    EFFECTIVE DATE: June 27, 1997.
    
    FOR FURTHER INFORMATION CONTACT: David L. Gordon, Center for Veterinary 
    Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., 
    Rockville, MD 20855, 301-594-1739.
    
        In FR Doc. 97-16791, appearing on page 34631 in the Federal 
    Register of Friday, June 27, 1997, the following corrections are made:
        1. On page 34631, in the first column, in the heading ``Tablet'' is 
    corrected to read ``Tablets''.
    
    
    Sec. 520.2098  [Corrected]
    
        2. On page 34632, in the first column, in Sec. 520.2098 Selegiline 
    hydrochloride tablets, in paragraph (d), the heading ``(d) Conditions 
    of use--'' is corrected to read ``(d)  Conditions of use--Dogs--''; and 
    in paragraph (d)(2), in the 4th line, ``hyperadrenocorticism.'' is 
    corrected to read ``hyperadrenocorticism in dogs.''
    
        Dated: September 8, 1997.
    Robert C. Livingston,
    Director, Office of New Animal Drug Evaluation, Center for Veterinary 
    Medicine.
    [FR Doc. 97-28017 Filed 10-22-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
6/27/1997
Published:
10/23/1997
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule; correction.
Document Number:
97-28017
Dates:
June 27, 1997.
Pages:
55158-55159 (2 pages)
PDF File:
97-28017.pdf